MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	980X3ENDIUU
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this 980 ventilator generated error messages.The device was available for evaluation.Based on the diagnostic code recorded in the ventilator logs the ventilator entered into backup ventilation.The service personnel (sp) inspected the ventilator, confirmed the reported issue with mix air flow out of range background diagnostic code in logs.As the ventilator also failed the zero offset test and air part of flow sensor crosscheck test.Sp replaced the proportional solenoid (psol) for air.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The cause of the event where the unit entered buv was isolated in the field to a potential fault in psol for air.The event is included in a data monitoring plan.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that while in use on a patient, this 980 ventilator generated error messages.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Section d9 was updated due to part return section h6 evaluation code result (annex c) additional code added due to analysis of part returned h3 device evaluation summary: was updated due to analysis of part returned.Medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this 980 ventilator generated error messages.The device was available for evaluation.Based on the diagnostic code recorded in the ventilator logs the ventilator entered into backup ventilation.The service personnel (sp) inspected the ventilator, confirmed the reported issue with mix air flow out of range background diagnostic code in logs.As the ventilator also failed the zero offset test and air part of flow sensor crosscheck test.The sp replaced the proportional solenoid (psol) for air.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One psol for air was returned to medtronic for analysis.A visual inspection revealed no external anomalies.The psol was installed in a failure investigation test ventilator for analysis.The unit failed the leak test, and further investigation determined the psol for air was faulty.If a failure of the psol for air occurs while in use on a patient, the ventilator response would be to enter into buv.The cause of the reported event and entry into buv was isolated to a faulty psol for air.The event is included in a data monitoring plan.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23834726
• Report Number: 8020893-2025-00275
• Device Sequence Number: 5068345
• Product Code: CBK
• UDI-Device Identifier: 10884521172524
• UDI-Public: (01)10884521172524(11)190605
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K193056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 980X3ENDIUU
• Device Catalogue Number: 980X3ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown